CleanCision Wound Retraction and Protection System
FDA 510(k) clearance K172132 · decided 2017-10-25
Clearance details
- K-number
- K172132
- Device name
- CleanCision Wound Retraction and Protection System
- Applicant
- Prescient Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-07-14
- Decision date
- 2017-10-25
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- PQI
- Device class
- 2
- Regulation number
- 878.4371
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Carlos, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Prescient Surgical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CleanCisionTM Wound Retraction and Protection System (DEN150038) | Prescient Surgical | 2016-12-16 |
Recalls involving this device
No recalls on record reference this clearance.